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FlexLink Worldwide

Catheter assembly line
The automated system increased capacity by 60% and reduced the number of products in process by 94%.

Previous system:
The products were wheeled on carts between the workstations. Quality control was executed sporadically according to instructions found in printed files. The number of manual workstations was 36 and 1200 products were assembled per day in two shifts. There were 9-10.000 products in process in the class 100.000 cleanroom facility.

Customer requirements:

  • An electronic quality assurance system to comply with FDA 21 CFR part 11.
  • Reduce the number of products in process
  • Increase efficiency of the plant
  • Possibility to automate stepwise
  • Possibility to easily relocate the line
  • Cleanroom class 100.000               

Our solution:

  • Flow control and flexible routing
  • Partition into 3 zones, each with defined logic: 
    Assembly, test and repair
  • Modular design of the line
  • Product information by escort memory
  • Defined logic for production test and repair            

Result:

Existing systemFlexLink assembly system
 
Logistics Carts Automated with pallets
Quality assurance
 
Manual, files Automated
 
Flexibility High High
Number of workstations 36
 
24
 
Whereof quality assurance
 
Sporadic
 
 
Four dedicated stations. All stations if on-line inspection is required.
Nominal capacity per day, two-shift 1200
 
1900+
 
Number of products in process 10 000
 
600
 

 

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